The Pharmaceuticals Medical Safety Officer (MSO) is a physician with training or experience in Medical Safety, who reports into the Medical Safety Organization and has accountability for assessing the medical safety of Company products and strategically leading cross-functional matrix teams responsible for product safety and benefit risk oversight.
The MSO will report to the Global Medical Safety (Client) Therapeutic Area (TA) Safety Head and oversee the safety assessment of assigned drugs within the TA that are marketed and/or in clinical development. Collaborating with relevant functions, the MSO will ensure proactive and timely assessments of safety data to characterize the emerging and known safety profiles and benefit risk of their products within the TA. The MSO will communicate potential and known risks, when appropriate, to the TA Safety Head, Head of Medical Safety Assessment (MSA), the Chief Safety Officer (CSO), the Pharmaceuticals Chief Medical Officer (CMO), the Qualified Person for Pharmacovigilance (QPPV) Pharma, Senior Management, Health Authorities (HA), Prescribers and/or Patients. In compliance with legal and regulatory requirements, the MSO will also lead when appropriate, in the design and implementation of risk mitigation strategies to ensure the safe and appropriate use of Company products.
Strategically lead the Safety Management Teams (SMT) for assigned products. SMT responsibilities include safety surveillance (including signal detection) and risk management activities (including Risk Management Plan (RMP) and Risk Evaluation and Mitigation Strategy (REMS)), as well as other activities related to managing the safety profile of assigned products
Provide medical and scientific expertise as the Client representative on the Compound Development Team (CDT) and Clinical Teams
Anticipate safety concerns and influence other relevant functions including Clinical teams to minimize/mitigate patient impact by active participation in the design of the clinical protocols.
Be an active partner and core contributor of safety input to key regulatory or clinical documents including:
- Risk management plans
- Safety development plan
- Clinical Trial Protocols
- Informed Consent Forms (ICF)
- Safety Sections of Investigator's Brochure (IB) and IB addenda
- Clinical Study Reports (CSR)
- Annual Safety Reports (ASR)
- Integrated Safety Summary (ISS) and Summary of Clinical Safety
(SCS) for NDA/BLA/MAA filings
- Periodic Benefit Risk Evaluation Report (PBRER) Safety Update Report (PSUR)
- Health authority queries
- Core Data Sheets (CDS)
Effectively communicate (verbally and in writing) important results of medical safety and benefit/risk management evaluations when necessary, to the Client Leadership Team, CMO, and the Pharmaceuticals Medical Safety Council (MSC)
Actively participate and contribute to meetings with Health Authorities and external key opinion leaders
Provide medical safety leadership on due diligence teams to evaluate Licensing & Acquisition opportunities
Provide medical oversight to contractors and non-physician staff involved in preparing written safety evaluations for their assigned products.
This will include:
-Defining the safety question or issue requiring medical safety assessment
-Developing the strategy for the safety review and analysis
-Interpreting results and determining the medical importance of question or issue
-Reviewing and approving (i.e., signatory) medical assessment reports, e.g. ad hoc safety reports
Work across the Client TAs to align and improve common processes including providing strong leadership and a harmonized approach across clinical teams for safety data collection, assessment, and safety-related processes and issues
Assist in the creation, review and implementation of new SOPs, Work Instructions, guidelines, documents and other tools pertaining to safety assessment and risk management
Lead or actively participate in department-wide initiatives
Takes a leadership role in influencing senior management and key stakeholders across the business to achieve strategic goals. Leads others by example in influencing internal and external partners; demonstrates openness and seeks to understand different perspectives; gains the trust of others; asserts personal ideas and opinions using persuasion to influence others; demonstrates excellent negotiation skills. Gathers diverse viewpoints; proactively influences others appropriately across departments, functional areas, and with external partners.
Is viewed as a trusted partner across the business and with internal and external therapeutic area experts; anticipates additional needed relationships and proactively takes actions; leverages relationships; develops strategic alliances and coalitions. Uses an active network of relationships to achieve goals; fosters teamwork within own department or function, as well as across departments or functions; proactively addresses organizational barriers to enhance team effectiveness; leads the development of productive relationships among senior leaders and across organizational boundaries. Proactively maintains relationships with internal and external business partners across departments and functions; contributes actively to the effectiveness of cross-functional teams; capitalizes on existing structures and procedures for effectively engaging with partners.
Reports to TA Safety Head, GMO
Global Medical Safety is a functional area within the Global Medical Organization.
Contacts Inside the Company:
All Clinical Therapeutic Areas
CSO
CMO, Pharma
QPPV Pharma
Medical Safety Officers and Scientists in Medical Safety Assessment
Other groups within GMO including Medical Safety Surveillance and Insight (MSSI) Pharmacovigilance Evaluation and Reporting (PVER), Risk Management Scientific Leads, Client Operations (GMSO), Compliance Standards and Analytics (CSA) and Alliance Management
Epidemiology
Strategic Product Development
Business Development
Global Regulatory Affairs and Global Labeling
Global / Regional Medical Affairs
CDOs, including Biostatistics and Regulatory Medical Writing
Contacts Outside the Company:
Clinical and Epidemiology Consultants and Advisors
Regulatory Agencies
Development Partners and Potential Partners
Business Partners
CROs
Education and Experience:
Physician (MD or equivalent), generally requires 2-5 years of pharmacovigilance experience or other relevant experience (e.g. Clinical research, Medical Affairs)
Board Certification (if US) preferred
Medical specialization preferred
Demonstrated skills in clinical medicine with at least 1 year of clinical practice experience
Demonstrated knowledge of principles of drug development, pharmacology, clinical trial methodology and design, medical monitoring of trials, assessment of drug risks and benefits, and safety assessment of drugs both on the market and in development and global safety regulations highly preferred
Ability to influence, negotiate and communicate with both internal and external stakeholders
Experience with Health Authority presentations is preferred.
Required Technical Knowledge and Skills:
Ability to effectively and strategically lead global cross-functional teams
Connect, collaborate and build consensus across relevant functions
Ability to think strategically, has a global mindset, big picture orientation, Ability to see the context of the entire situation, understand implications to the business
Ability to critically evaluate safety data from multiple sources (clinical trials, environment, literature, etc), assess clinical importance and potential strategic impact of the data and present the findings clearly in both written and oral communications.
Experience and knowledge of Good Clinical Practices and Pharmacovigilance regulatory requirements in US, the EU and globally, the conduct of clinical trials and for the appropriate contributions to regulatory filings, PV documents and risk management plans
Able to plan work to meet deadlines and effectively handle multiple priorities
Excellent verbal and written communication skills, including formal presentation skills. Written skills as evidenced by publication and journal articles also desirable
Fluent in written and spoken English
Proficiency in Word and PowerPoint is desired
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Last updated on Oct 28, 2020